The aim of this study is to evaluate the activity of a maintenance therapy with everolimus 10 mg daily in patients with stable disease, partial response or complete response after 6 cycles of induction chemotherapy with cisplatin or carboplatin plus etoposide administered according to clinical practice.
Conditions
Interventions
Trade Name: AFINITOR®
Product Name: AFINITOR®
Pharmaceutical Form: Capsule
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Current Sponsor code: ABI-007
Other descriptive name: EVEROLIMUS
Conc
Sponsors
Gruppo Oncologico Italiano Ricerca Cancro (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: • Histological / cytological diagnosis of GEP Neuroendocrine Carcinoma (NEC) with Ki67 18; • ECOG performance status = 2; • Adequate bone marrow function (Hb> 9.0 g / dL, absolute neutrophil count> 1.5 x 109 / L, platelets> 100 x 109 / L), renal function (serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • clinically significant cardiovascular disorders in the 6 months prior to randomization (congestive heart failure, myocardial infarction, unstable angina, severe uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular accidents, pulmonary thromboembolism); • Functional Neuroendocrine Carcinoma NEC • Neuroendocrine carcinoma with ki 67 > 55% • ongoing uncontrolled infection; • Concomitant intake of: - Drugs incompatible with concomitant everolimus; - Any other drug in clinical trials; • History of other malignancy except carcinoma in situ of the cervix or basal / squamous cell carcinoma of the skin adequately treated; • Presence of brain metastases; • Any other serious or uncontrolled concurrent disease conditions that the safe administration of medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is progression free survival (PFS) defined as the time between randomization and the first evidence of progressive disease or date of death, whichever occurs first. Documentation of disease progression will be defined as per RECIST 1.1 criteria based on investigator assessment. The censoring date for a patient who is known to be progression-free would be the date of the last tumor assessment. ;Secondary Objective: Overall survival (OS) defined as the time from randomization to death from any cause Safety profile: Safety of the treatment will be evaluated by serious and non serious adverse events (AEs). AEs will be graded according to the CTCAE v4.03 Evaluation of prognostic/predictive factors on tumoral tissue and blood samples of patients treated with maintenance Everolimus:;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS), safety profile, evaluation of prognostic/predictive factors on tumoral tissue and blood samples ;Timepoint(s) of evaluation of this end point: 10 months for OS and during maintenace treatment for safety profile and evaluation of prognostic/predictive factors on tumoral tissue and blood samples | — |
Countries
Italy
Contacts
Public ContactUfficio Trials clinici
GOIRC
Outcome results
None listed